Diet supplement--product (other than tobacco) that is intended to supplement the diet containing one or more of the dietary ingredients listed here vitamin, mineral, an herb or other botanical, an amino acid, a dietary supplement used by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any ingredient described above

DSHEA--Dietary Supplement Health and Education Act, passed in October, 1994 allowed for labeling and selling of dietary supplements with little to no oversight by the FDA

Clin Obstet Gynecol, 44(4), Dec. 2001, 780-788 6Definitions

Allopathy--A therapeutic system in which disease is treated by producing a second condition that is incompatible with or antagonistic to the first. Conventional medicine in the United States.

7Definitions

Homeopathy--System of therapy developed by Samuel Hahnemann based on the law of similia, from the aphorism, simila similibus curantur (likes are cured by likes), which holds that a medicinal substance that can evoke certain symptoms in healthy individuals may be effective in the treatment of illnesses having symptoms closely resembling those produced by the substance

Therapy mediated through the potentiation of substances which are prepared with serial dilutions, often to the point in which no molecules of the active substance is detectable

Flourished during the 1800s when patients often did better than those treated with blood letting, emetics and other treatments.

8Definitions

Acupuncture

2,000 acupuncture points on the body

Connected via 12 main and 8 secondary pathways (Meridians)

Meridians connect energy, qi (chee), between the surface of the body and the internal organs

Qi regulates spiritual, emotional, mental and physical balance

Qi is influenced by the opposing forces of yin and yang

When yin and yang are balanced, they work with the natural flow of qi to keep the body healthy

The placement of needles in the acupuncture points helps to keep the flow of qi unblocked.

187 women over 21 days with nerve stimulation at P6 with ReliefBand (Woodside Biomedical, Carlsbad, CA.) or sham device

Self-reporting scores for N/V decreased significantly

Study group gained more weight (2.9 lbs vs. 1.2, P0.003)

No significant change in medication use between groups

Obstetrics Gynecology, 2003102129-135 17Acupunctures uses for OB/GYNsInduction of Labor Study from Vienna took 45 women at 40 weeks and administered treatment every other day for up to 10 days. Study group had statistical significant cervical shortening and interval to delivery (5.0 vs. 7.9 days) Two studies in Norway had mixed conclusions on use of a single acupuncture treatment after confirmation of SROM At UNC we took 56 nulliparous women at 394 weeks or beyond and half received 3 daily treatments. Study group was more likely to labor spontaneously and less likely to need a C/SRabl M, et. al., Wien Klin Wochenshr, 113, 2001, 942-946 J. Mat-Fetal Neonatal Med Aug. 2006 19(8), 465-70 Acta Obstetricia et Gynecologica, 85, 2006, 1348-1353, Acta Obstetricia et Gynecologica, 86, 2007, 1447-1452 18Acupuncture is not without potential risksInfections One-hundred twenty-six cases of Hepatitis B have been linked to acupuncture Evidence for Hepatitis C infection in Japan A few reported cases of HIV infection as well Subacute bacterial endocarditis Trauma Thirty two cases of Pneumothorax have been reported Cardiac tamponadePain, 71(1997), 123-126 19Herbs, Dietary Supplements and your Patients 20

Use of dietary supplements is common among the U.S. adult population.

gt40 used supplements in 19881994

gt50 in 20032006

Patients do not stop their herbal supplements during pregnancy

Among the 53 of adults gt50 yrs using CAM, 58 reported that they have ever discussed CAM with a healthcare provider

61 said it wasnt important for my doctor to know, 60 said the doctor never asked.

AARP, NCCAM. Complementary and Alternative Medicine What People Aged 50 and Older Discuss With Their Health Care Providers. Consumer Survey Report April 13, 2010 Gache, J et al. Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES III (19881994) . NCHS Data Brief. April 201161. JAMA 200228737-344, Am J Obs GYN 2003188(4)1039-1045, Ann Intern Med 2001135344 21What are Herbal Medicines?Herbal forms of medications are often dietary supplements They are in the form of tablets or capsules, bulk herbs, oils, teas or tinctures (alcohol extracted concentrates added to liquid) Soup, potato chips or beverages that contain herbal ingredients are not dietary supplements, they are foods and regulated by the FDA There is no standardization as to concentration of herbal medicines, or whether it is a raw botanical component or a distillation. Herbs themselves often have multiple ingredients which may have biologic effect, so it is difficult to tell which ingredient is producing an effect, if anyClin Obstet Gynecol 44(4), Dec. 2001 780-788, ACOG Practice Bulletin, No. 28, June 2001 22Herbal MedicinesAbout 30-40 of our drugs are grown in plant-form or are photochemicals made in a laboratory Well known drugs today were first discovered in plants AtropineBelladona CodeinePoppy DigoxinFrom foxglove EphedrineEphedra Salicylic acidWillow bark ScolpolamineJimson weed QuinineFrom Cinchona bark TaxolPacific yew VincristineMadagascar periwinkleBMJ 319, Oct. 16, 1999, 1050-1053 Clin Obstet Gynecol, 44(4), Dec. 2001, 853-863, www.uptodate.com 23If it is Natural it must be safe, right? 24(No Transcript) 25Areas of Concern with Herbal MedicinesToxic effects Dangerous interactions with other medications Discontinuing known and effective conventional therapies 26What are Herbal Supplements used for?

Generalized Health

Menopausal symptoms

Mood Disorders

Weight Loss

27Most Common Herbal Products Being Used

Echinacea (40.3)

Ginseng (24.1)

Ginkgo Biloba (21.1)

Garlic (19.9)

St. Johns wort (12.0)

Peppermint (11.8)

Ginger (11.7)

Soy (9.4)

Barnes, Complementary and alternative medicine use among adults, Advance Data from Vital Statistics, US Dept of Health and Human Services, Rockville, MD 2004 28Black Cohosh(Actaea Cimicifuga racemosa, black snakeroot)Traditionally used by Native Americans for gynecologic conditions Used today primarily for treatment of menopausal symptoms We really do not know the mechanism of action in black cohosh We do know that Black Cohosh is not estrogenic as it has no impact on the vaginal cell status, LH, FSH, estradiol, prolactin or endometrial thickness in comparison to baselineAnn Intern Med 137(10), Nov. 19, 2002 805-813, Menopause 10(4) 2003299-313 Menopause 15(1) 2008, 51-58 29Black CohoshThere are small studies that imply that it decreases the intensity of vasomotor symptoms for menopausal women Most studies performed with black cohosh for menopausal symptoms did not last longer than 6 months Most studies have been done in Germany where black cohosh is approved for treatment of symptoms of the climacteric Almost all studies done on black cohosh is the formulation Remifemin, distributed by GlaxoSmithKline in the US Clin Obstet Gynecol 44(4), Dec. 2001, 853-863, Ann Intern Med 137(10), Nov 19, 2002, 805-813, Menopause 10(4)2003 299-313, Obstetrics Gynecology 2006107247-255. 30Black Cohosh

There have been multiple (about 50) reported cases of hepatoxicitythough no known mechanism to explain it

Regulatory agencies in Australia, Canada and the European Union warn about hepatoxicity

US Pharmacopeia states black cohosh should have cautionary statement on label

Menopause, 15(4), 2008, 628-638 33Black Cohosh is NOT Blue Cohosh

Blue Cohosh (Caulophyllum thalictroides) has a very different therapeutic profile

Both are sometimes referred to as Squaw root

Blue Cohosh is a vasoconstrictor with mild uterine effects. Sometimes used to induce labor

Case reports of abruption and neonate seizures linked to Blue Cohosh

34St. Johns Wort(Hypericum perforatum)Named after St. John the Baptists birthday (6/24) when it typically blooms Multiple RCTs show that it is better than placebo for MILD to MODERATE depression Other RCTs show that it is as effective as prescription antidepressants with fewer side effects NO better than placebo for MAJOR depression Side effects include mild HA, gastric upset, dizziness, fatigue and photosensitivity MAJOR concern for herb-drug interactionAnn Intern Med 200213642-35, Linda K et al Cochrane Database Systematic Review 2005CD000448 35St. Johns Wort

Induces the CYP3A4 isozyme of the P-450 system

CYP3A4 isozyme is responsible for metabolizing more than 50 of all prescription drugs

Bitter Orange(Citrus aurantium, green orange). Marketed for weight loss. Works just like ephedera, can theoretically cause hypertension, stroke and other cardiac problems. Only 1 RCT which showed no benefit.

GarlicMarketed for lowering cholesterol and to help with hypertension. Nausa/vomitting, diarrhea, contact dermatitis, inhibition of iodine uptake, decreases platelet aggregation and increases INR in patients on warfarin. Wide range of concentrations. May be important to discontinue use prior to procedures and surgeries

EchinaceaOften used to treat the common cold. Herbal products usually draw from closely related species, E. pururea, E. pallida or E. angustifolia. Two NIH studies have shown no benefit for shortening cold or flu symptoms. May be helpful in URIs. GI side effects are most common, but can cause mild to severe reactions in those allergic. People with allergies to other plants in the daisy family are more susceptible (ragweed, daisy, marigolds).

http//nccam.nih.gov/health/echinacea/ 44In Review

There are all types of CAM out there

As insurance begins to pay for CAM, you may be asked for a referral

Some evidence that Black Cohosh, St. Johns Wort and acupuncture work for certain conditions

Remember the concept of do no harm

Ask your patients what other therapies they are using, especially before an upcoming surgery

45Resources

The National Library of Medicine http//www.ncbi.nlm.nih.gov/PubMed/

The National Center for Complementary and Alternative Medicine http//nccam.nih.gov/

The NIH Office of Dietary Supplements http//ods.od.nih.gov/

Quackwatch http//www.quackwatch.com

To report an adverse event with a supplement http//www.fda.gov/medwatch

Natural Standard database www.naturalstandard.com

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